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ANSI/AAMI ST65:2008/(R)2018 - Processing of reusable surgical textiles for use in health care facilities, 2008
- ANSI/AAMI ST65:2008/(R)2018, Processing of reusable surgical textiles for use in health care facilities
- Objectives and uses of AAMI standards and recommended practices
- Title page
- AAMI Recommended Practice
- Copyright information
- Contents
- Glossary of equivalent standards
- Committee representation
- Foreword
- Introduction: Need for the recommended practice
- 1 Scope [Go to Page]
- 1.1 General
- 1.2 Inclusions
- 1.3 Exclusions
- 2 Definitions, symbols, and abbreviations
- 3 Design considerations [Go to Page]
- 3.1 General rationale
- 3.2 Work area design and functional work flow [Go to Page]
- 3.2.1 Definitions of work areas [Go to Page]
- 3.2.1.1 Laundry area
- 3.2.1.2 Surgical pack assembly area
- 3.2.1.3 Other areas
- 3.2.2 Design criteria for work areas
- 3.2.3 Functional work flow patterns [Go to Page]
- 3.2.3.1 Laundry area
- 3.2.3.2 Surgical pack assembly area
- 3.2.4 Traffic control
- 3.3 Physical facilities: laundry area [Go to Page]
- 3.3.1 Space requirements
- 3.3.2 Mechanical systems
- 3.3.3 Floors, walls, ceilings, and vents
- 3.3.4 Ventilation
- 3.3.5 Temperature and humidity control
- 3.3.6 Lighting systems
- 3.3.7 Handwashing facilities
- 3.3.8 Emergency eyewash/shower equipment
- 3.3.9 Soil-sort area
- 3.3.10 Chemical storage area
- 3.3.11 Storage area for clean textile packs
- 3.3.12 Housekeeping
- 3.4 Physical facilities: surgical pack assembly area [Go to Page]
- 3.4.1 Space requirements
- 3.4.2 Mechanical systems
- 3.4.3 Floors, walls, ceilings, and vents
- 3.4.4 Ventilation
- 3.4.5 Temperature and humidity control
- 3.4.6 Lighting systems
- 3.4.7 Hand hygiene facilities
- 3.4.8 Storage area for clean textile packs
- 3.4.9 Surgical pack sterilization area
- 3.4.10 Sterile storage area
- 3.4.11 Housekeeping
- 4 Personnel considerations [Go to Page]
- 4.1 General rationale
- 4.2 Qualifications [Go to Page]
- 4.2.1 Supervisors/managers
- 4.2.2 Personnel
- 4.3 Training and education
- 4.4 Health and personal hygiene
- 4.5 Attire [Go to Page]
- 4.5.1 General
- 4.5.2 Personal protective equipment (PPE)
- 5 Receiving and handling of reusable surgical textiles [Go to Page]
- 5.1 General rationale
- 5.2 Newly purchased items [Go to Page]
- 5.2.1 Identification and handling
- 5.2.2 Washing
- 5.3 Collecting and transporting soiled surgical textiles [Go to Page]
- 5.3.1 Collecting soiled surgical textiles at the point of use
- 5.3.2 Transporting soiled surgical textiles
- 5.4 Sorting of soiled textiles [Go to Page]
- 5.4.1 General considerations
- 5.4.2 Pre-sort systems
- 5.4.3 Post-sort systems
- 6 Laundry processing recommendations [Go to Page]
- 6.1 General rationale
- 6.2 Washing [Go to Page]
- 6.2.1 Procedures
- 6.2.2 Loading of washing equipment
- 6.2.3 Steps in the washing process: laundry formulas [Go to Page]
- 6.2.3.1 General considerations
- 6.2.3.2 Flush
- 6.2.3.3 Break
- 6.2.3.4 Main wash (suds)
- 6.2.3.5 Bleach
- 6.2.3.6 Rinsing
- 6.2.3.7 Finishing (final rinsing)
- 6.2.3.8 Extraction
- 6.3 Drying [Go to Page]
- 6.3.1 Procedures
- 6.3.2 Equipment loading
- 6.3.3 Steps in the drying process: drying formulas [Go to Page]
- 6.3.3.1 General considerations
- 6.3.3.2 Heating
- 6.3.3.3 Cooling
- 6.4 Process monitoring [Go to Page]
- 6.4.1 Rationale for process monitoring
- 6.4.2 Process monitoring: supplies [Go to Page]
- 6.4.2.1 General considerations
- 6.4.2.2 Verification of laundry chemicals used
- 6.4.2.3 Pump delivery system
- 6.4.2.4 Water quality
- 6.4.2.5 Type and load size of soiled textiles being processed
- 6.4.3 Process monitoring: equipment operation
- 6.4.4 Process monitoring: finished products
- 7 Inspection, testing, and maintenance of laundered textiles [Go to Page]
- 7.1 General rationale
- 7.2 Visual inspection [Go to Page]
- 7.2.1 Quality standards
- 7.2.2 Stains
- 7.2.3 Physical defects
- 7.2.4 Chemical or thermal damage
- 7.2.5 Foreign debris
- 7.2.6 Labeling
- 7.2.7 Tracking system
- 7.3 Testing [Go to Page]
- 7.3.1 Test procedures
- 7.3.2 Microbiological cleanliness
- 7.3.3 Effective life
- 7.3.4 Important functional attributes [Go to Page]
- 7.3.4.1 General considerations
- 7.3.4.2 Barrier efficacy
- 7.3.4.3 Liquid/fluid control
- 7.3.4.4 Strength properties
- 7.3.4.5 Drapeability
- 7.4 Maintenance [Go to Page]
- 7.4.1 Patching
- 7.4.2 Mending
- 7.4.3 Rewash
- 7.4.4 Rejuvenation
- 7.4.5 Retirement or alternate use
- 8 Preparation and packaging [Go to Page]
- 8.1 General rationale
- 8.2 Procedures
- 8.3 Folding [Go to Page]
- 8.3.1 General considerations
- 8.3.2 Guidelines for folding gowns
- 8.3.3 Guidelines for folding drapes [Go to Page]
- 8.3.3.1 General considerations
- 8.3.3.2 Back table cover
- 8.3.3.3 Overhead table cover with skirt
- 8.3.3.4 Mayo stand cover
- 8.3.3.5 Sheets
- 8.3.3.6 Fenestrated drapes
- 8.3.3.7 Draping systems
- 8.3.3.8 Ancillary products
- 8.4 Pack assembly
- 8.5 Wrapping
- 8.6 Labeling/identification of packs
- 9 Handling, transport, and storage of laundered textiles [Go to Page]
- 9.1 General rationale
- 9.2 Procedures
- 9.3 Personnel attire and hygiene
- 9.4 Handling clean/sterile textiles
- 9.5 Transport [Go to Page]
- 9.5.1 General considerations
- 9.5.2 Method of transport
- 9.5.3 Separation of clean/sterile and soiled textiles
- 9.5.4 Laundry cart cleaning, disinfection, and loading [Go to Page]
- 9.5.4.1 Cleaning and disinfection
- 9.5.4.2 Loading
- 9.5.5 Truck cleaning and loading
- 9.6 Storage [Go to Page]
- 9.6.1 Storage conditions
- 9.6.2 Storage shelving
- 9.6.3 Stock rotation
- 10 Installation, operation, care, and maintenance of laundry equipment [Go to Page]
- 10.1 General rationale
- 10.2 Documentation [Go to Page]
- 10.2.1 Identification
- 10.2.2 Safety
- 10.2.3 Manuals and installation/operating instructions
- 10.3 Installation [Go to Page]
- 10.3.1 General considerations
- 10.3.2 Utilities [Go to Page]
- 10.3.2.1 General considerations
- 10.3.2.2 Water quality
- 10.3.2.3 Electrical power
- 10.3.2.4 Gas
- 10.3.2.5 Steam
- 10.4 Operation [Go to Page]
- 10.4.1 General considerations
- 10.4.2 Washing, extraction, and drying equipment [Go to Page]
- 10.4.2.1 General considerations
- 10.4.2.2 Mechanical systems
- 10.4.2.3 Automated controls
- 10.4.3 Support systems [Go to Page]
- 10.4.3.1 General considerations
- 10.4.3.2 Washer chemical delivery systems
- 10.4.3.3 Water softeners
- 10.4.3.4 Water heaters
- 10.4.3.5 Boilers
- 10.4.3.6 Air compressors
- 10.4.3.7 Heat exchangers
- 10.4.3.8 Water reuse systems
- 10.5 Routine care and maintenance [Go to Page]
- 10.5.1 Routine care
- 10.5.2 Scheduled (preventive) maintenance
- 10.5.3 Unscheduled maintenance (repairs)
- 10.5.4 Calibration
- 10.5.5 Recordkeeping
- 11 Quality control [Go to Page]
- 11.1 General rationale
- 11.2 General quality control criteria [Go to Page]
- 11.2.1 Functional performance criteria
- 11.2.2 Verification of laundry processes
- 11.3 Policies and procedures
- 11.4 Barrier efficacy
- 11.5 Tracking uses of reusable surgical textile products
- 11.6 Process performance [Go to Page]
- 11.6.1 Quality assessment
- 11.6.2 Quality process
- 12 Medical device regulatory considerations
- Annex A Examples of folding procedures
- Annex B Bibliography [Go to Page]
- B.1 Cited references
- B.2 For further reading [Go to Page]